Tag Archives: BIOCON

New Biocon Ph1 Oral Insulin Trial

A CT.gov record for a new Ph1 trial evaluating Biocon’s oral insulin Tregopil has been observed. Of note, the trial is being conducted by Profil in Mainz, Germany. Below, FENIX provides thoughts and insights into insulin Tregopil’s development including the challenges and commercial opportunity particularly around cold chain storage in underdeveloped geographies.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Biocon CY Q3 ’19 (FY Q2 ’20) Earnings Update

Biocon hosted its CY Q3 ’19 (FY Q2 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine, bs-aspart and bs-rHI. Recall, Biocon/Mylan received a CRL from FDA for bs-glargine submission in September 2019 (previous FENIX insight). Of note, Biocon indicated it is confident in resolving the CRL and anticipates FDA approval prior to the March 2020 insulin reclassification. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Mylan Faces Setback in Sanofi Bs-Glargine Lawsuit

According to new court documents, the presiding judge in the Sanofi v. Mylan glargine lawsuit has denied Mylan’s request to rule two Lantus formulation patents invalid. The trial to settle the ongoing patent dispute is scheduled to start on December 2, 2019. Below, FENIX provides thoughts on the judge’s ruling and the potential impact on the Mylan/Biocon bs-glargine US launch timeline.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon/Mylan Glargine CRL; BI/ZEAL Dual Agonist Moves to Ph2; Vertex Acquires Semma

Three key pieces of news have recently been observed: Biocon/Mylan received a CRL from FDA regarding their bs-glargine Malaysian manufacturing facility, Boehringer Ingelheim is advancing its dual agonist into Ph2 (licensed from Zealand), and Vertex entered into a definitive agreement to acquire Semma Therapeutics. Below, FENIX provides thoughts and insights on the respective news items including the uncertainty around Biocon/Mylan’s glargine in the context of the merger with Pfizer.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon’s Glargine Facility Receives EU GMP Certification

Yesterday, Biocon announced it received EU GMP certification from EMA for its integrated insulin facility in Malaysia, which was inspected in May 2019. Biocon’s Malaysian facility manufactures insulin glargine and rh-insulin. Below, FENIX provides additional thoughts on the EU GMP certification in the context of the recent FDA 483 observations and impending Biocon/Mylan bs-glargine US launch.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon Malaysian Facility Receives Additional 483 Observations From FDA

Biocon has received an additional twelve 483 observations from an FDA inspection of Biocon’s Malaysian facility. The 483 observations were a result of an FDA pre-approval inspection for the bs-glargine product; however, the company did not provide any specific details. No result was found during a search of FDA’s inspection citations. According to Biocon, the inspection is not anticipated to impact plans for US commercialization. Below, FENIX provides context and insight regarding these 483 observations.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon/Mylan Glargine CRL; Biocon and Merck Q2 ’18 Earnings

Biocon hosted its CY Q2 ’19 (FY Q1 ’19) earnings call and provided an update on its biosimilar glargine development program including the CRL that was issued in early June 2018. Additionally, Merck hosted its Q2 ’18 earnings call and briefly touched on its diabetes business unit. Below, FENIX provides an overview of the calls and insight on Biocon’s glargine CRL.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon Bangalore facility receives 7 form 483 observations from FDA

Biocon has reportedly received 7 Form 483 observations from FDA for its Bangalore facility. According to the report, the Bangalore facility observations are “largely procedural and aimed at continuous improvement.”

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon Malaysian facility receives six form 483 observations from FDA

Biocon has reported that FDA issued a form 483 with six observations for its Malaysian facility. Recall, this facility is primarily responsible for the manufacturing of insulins including its biosimilar glargine. Biocon did not provide further details into the FDA observations.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon CY Q4 ’17 (FY Q3 ’18) Earnings Update

Biocon hosted its CY Q4 ’17 (FY Q3 ’18) earnings call and provided updates on its insulin portfolio including bs-glargine regulatory status, bs-aspart Ph1 initiation, and Tregopil (oral insulin) Ph2/3 initiation in India. Below are highlights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.